Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the
immediate and short term (one month) impact of a new long acting double bronchodilator on
innovative parameters in stable and moderate to severe COPD patients.
- Variability and complexity of resting tidal breathing
- Oscillatory resistance and reactance of airways Tidal volume variability and complexity
is decreased in airway obstruction and is expected to improve with a bronchodilator
treatment, together with lung mechanics.
The relationship with changes in dyspnea and conventional pulmonary function tests is the
second aim of study.
After baseline assessment of these parameters, clinical and lung function evaluation will be
performed 2 hours post-drug (peak drug effects). Patients will continue treatment with PT003
for 4 weeks. On Day 30, the same clinical and lung function assessments will be performed pre
(trough) and 2h-post dose in order to obtain after-treatment measurements.